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Quality Systems Compliance 1
FDA Medical Device Quality Systems Compliance
Quality Systems Compliance 2
Agenda• Introductions, Attendance Sign in • Domestic and International Quality Systems • Food and Drug Law • Organization of the FDABreak ( 15 min)• Procedures• FDA Quality Systems Regulations ( 21 CFR 820)Lunch• Labeling• Complaint Handling• Record KeepingBreak (15 Min)• FDA Quality Systems Audits• Exam• Course Evaluations
Quality Systems Compliance 3
US and European Regulatory Systems
Congress Passes Laws
US
FDA Writes Regulations
Companies Develop Quality Systems Procedures
FDA Audits for Compliance to Regulations
European System
European Commission Issues Directives
Member Countries identify independent Notified Bodies
Harmonized Standards adopted by the Member Countries
Notified Bodies Audit for Compliance to the Directive and Harmonized Standards
Quality Systems Compliance 4
US vs European Laws
US• Food, Drug and
Cosmetics Act• Medical Device
Amendments (1976)• Safe Medical Devices
Amendments (1990)• FDAMA (1997)
Europe• Medical Device
Directive (MDD) 1993• Active Implantable
Medical Device Directive (AIMD) 1990
Quality Systems Compliance 5
US vs. European Quality System Requirements
US• 21 CFR 820
(Also known as the QSR)
• Guidance Documents
Europe• Essential Requirements• Harmonized Standards• ISO 13485
Quality Systems Compliance 6
Background of the FDA
• Biologics Control Act. 1902
• The Pure Food and Drug Act-1906
• Food Drugs and Cosmetics Act -1938– Medical Device Amendments to the FDCA –
1976– Safe Medical Devices Act- 1990– FDAMA- 1997
Quality Systems Compliance 7
CBERCenter for Biologics
Evaluation and Research
CDRHCenter for Devices and
Radiological Health
CDERCenter for Drug
Evaluation and Research
Offices of Medical Product Regulation within theOffices of Medical Product Regulation within theU.S. Food and Drug Administration (FDA)U.S. Food and Drug Administration (FDA)
Quality Systems Compliance 8
Drugs “[an article] intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease . . . [or] . . . intended to affect the structure or any function of the body” FD&C Act, §201(g)(1)
Devices
“. . . An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease . . . or intended to affect the structure or any function of the body . . . and which does not achieve any of its primary intended purposes through chemical action within or on the body . . . and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes” FD&C Act, §201(h) (emphasis added)
Biologics “ . . .any virus, therapeutic serum, toxin, anti-toxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment or cure of diseases or injuries” PHS Act, §351(a)
DefinitionsDefinitions
Quality Systems Compliance 9
FDA Center Responsibilities
Blood Products
Vaccines
Gene/Cell Therapy
Stem Cell Research
Stethoscopes
MRI Scanners
Hemodialysis Machines
Surgical Instruments
Microwave ovens
Zocor
Viagra
Tylenol
Celebrex
Penicillin
CBER CDRH CDER
Quality Systems Compliance 10
RegulationsCBER CDRH CDER
Biologics
•21 CFR 600/601/610
Blood
•21CFR 606
CLIA
21CFR 1270, 1271 (tissue)
21 CFR 58 (GLP)
21CFR 11 (electronic records)
Devices
•21 CFR 21 CFR 820 QSR (GMP)•21 CFR 56 (IRB’s)
•21 CFR 58 (GLP)
•21CFR 11 (Electronic records)
•21 CFRR 800-1050 (devices)
•21 CFR 807 (510(k))
•21 CFR 812 (IDE)
Drugs
• 21 CFR 56 (IRB’s)
• 21 CFR 58 (GLP)
• 21CFR 11 (Electronic records)
•21 CFR 210, 211 (Drug GMP’s)
• 21 CFR 312 (IND)
• 21 CFR 314 (NDA)
Quality Systems Compliance 11
Class Exercise - FDA Organization
Which division of the FDA has authority over the following products?
• Blood banks• Bandages• Computer terminals• Bone graft material• Pre-filled antibiotic syringes• Lasers for eye surgery• Artificial skin graft materials• Contact Lenses• Dog and Cat Food
Quality Systems Compliance 12
Quality System
A Medical Device Quality System is designed to assure that products are Safe and Effective for their Intended Use
and
Consistently meet the specifications as defined by results of clinical and/or detailed technical design and validation
Quality Systems Compliance 13
Quality Control
Quality Systems Compliance 14
Quality Systems Compliance 15
Quality System Basics (ctd)
• Quality is everyone’s responsibility
• Quality has measurable attributes
• Specifications are the of a Quality System
• Documented policy and procedures contribute to consistency
• Quality planning is essential
Quality Systems Compliance 16
Quality Systems Basics (ctd)
• Clinical evaluation is the basis for safety and effectiveness
• Design Controls and validation assure that designs meet clinical expectations and specifications
• Process validation assures consistency• Identification, segregation and control of
materials and products prevents mix-ups• Documentation control is essential
Quality Systems Compliance 17
Quality System Basics (ctd)
• Corrective and preventative action systems foster continual improvement
• Labeling is important
• Internal and external (FDA) auditing keeps quality systems up to date
Quality Systems Compliance 18
The Documentation Pyramid
Quality Manual
Procedures
Work Instructions
Records (forms, notebooks, travelers)
Quality Systems Compliance 19
Important Terms
• Device Master Record (DMR)-
• Device History Record (DHR)
• Design History File (DHF)• Technical File• Complaint• Corrective Action• Controlled Document• Engineering Change Order
(ECO)
• Labeling• Verification • Validation• Traceability• Medical Device Directive
(MDD)• Essential Requirements• Notified Body
Quality Systems Compliance 20
Procedures
FDA 21 CFR 820 requires following written procedures
Quality Systems Compliance 21
Group Exercise: Draw a House
Quality Systems Compliance 22
Draw A House1. Read all instructions before beginning to draw the house2. Draw your house in the lower ½ of the page3. Begin by drawing a rectangle approximately 4 inches wide by 3 inches tall,
with the long side parallel to the bottom edge of the paper. The bottom of the rectangle should be 1 inch from the bottom of the paper.
4. Locate the center of the top edge of the rectangle. Put a small dot at that point.5. Put a small dot 1 ½ inches above the dot you just made. This dot will be
above the rectangle.6. Draw a line from the new dot to each edge of the top of the rectangle.7. Draw a door in the center of the rectangle. The door should be 3/4 inch wide
by 2 inches tall. The bottom of the door should touch the bottom of the rectangle.
8. Draw a window, approximately 1 inch square on each side of the door, 1 inch from the bottom of the rectangle. Hint: A average thumb is about 1 inch wide at the knuckle. The edge of each window should be ¼ inch from the nearest edge of the door.
9. Draw 4 panes of glass in each window by making a cross in each window. Each pane should be the same size.
10. Draw a chimney on the left side of the roof of the house. The chimney should be parallel to the left wall of the rectangle, touching the roof. The chimney should be ½ inch wide by 1 inch tall and go straight up.
11. Draw some smoke coming from the chimney. A squiggly line will represent smoke.
12. Put your pencil down when you are finished.
Quality Systems Compliance 23
Quality System Processes• Management Controls• Design Controls• Materials Controls• Document Controls• Purchasing Controls• Production and Process Controls• Facilities and Equipment Controls• Document, Record and Change Controls• Corrective and Preventative Action• Labeling Controls• Handling, Storage, and Distribution controls• Servicing Controls• Statistical Techniques
Quality Systems Compliance 24
Management Controls
• Possible careers – Internal Auditor– External Auditor– Quality Specialist– Quality Systems
Trainer
Quality Systems Compliance 25
Who is an Auditor?
An AuditorAuditor is someone who comes in after the war is lost to bayonet the wounded…
Anon.
Quality Systems Compliance 26
Management Controls21CFR 820 Subpart B
• Quality Policy Defined
• Management Representative
• Management Review
• Quality Systems Procedures
• Quality Systems Audits
• Trained Personnel
Quality Systems Compliance 27
Design Controls
• Possible Careers– Design Engineer or
Technicians– Quality Test
Technicians– Clinical Specialists– Documentation
Specialists
Quality Systems Compliance 28
Design Controls
A Medical Device Quality System is designed to assure that products are Safe and Effective for their Intended Use
and
Consistently meet the specifications as defined by results of clinical and/or detailed technical design and validation
Quality Systems Compliance 29
Design Controls
• A Design Control System is intended to design products which
• provide safe and effective medical devices,• meet the clinical needs of the intended patient population, • provide outstanding value to the user, • satisfy the needs and expectations of our customers.
• Phased approach to product development• Each phase has deliverables• Design reviews are the checkpoints
Quality Systems Compliance 30
Design Control Elements
• Design Planning• Design Input (Requirements)• Design Output (Specifications)• Design Reviews (Technical)• Design Verification (Meets Specifications• Design Validation (Meets clinical needs) • Design Transfer- (Moves from Design to
Manufacturing)• Design Changes (Formal Process)• Design History File (DHF)
Quality Systems Compliance 31
Design Planning
• Feasibility Studies
• Risk Assessments
• Project Plan Defines Interfaces with Others
• Stage-Gate Methodology
• Constantly Changing
Quality Systems Compliance 32
Design Input• Where
– Customers– Technical Papers– Medical experts– Service people
• What– Intended Use– Technical Requirements– Safety Issues
• How– Documented– Approved– Filed– Formal Change Control System
Quality Systems Compliance 33
Design Output
• Final Design Specifications– Quantitative – Documented– Approved
• Final Risk Assessments
• Clinical Testing May Be Needed
Quality Systems Compliance 34
Design Reviews
• Planned Formal Technical Reviews
• Independent Member of Review Team
• Documented
Quality Systems Compliance 35
Design Verification And Validation
• Verification - Meets Specification
• Validations - Meets Intended Clinical Use
• Written Procedure Required
• Testing Must be Documented, Reviewed and Approved
• Software Must be Validated
• Manufacturing Processes Must be Validated
Quality Systems Compliance 36
Design Transfer
• Design moves from R&D to Manufacturing• Manufacturing and Production
Specifications are Documented • Manufacturing IQ, OQ, PQ
– IQ - Installation Qualification (Equipment)– OQ - Operational Qualification( 1st ones meet
specs)– PQ - Performance Qualification (Consistently
repeatable)
Quality Systems Compliance 37
Design Changes
• All changes to the design after release must be controlled (Engineering Change Control)– Re-validation may be needed
• Continues for the Life of Product
Quality Systems Compliance 38
Design History File
• Record of the Development Process– Plans– Specifications– V&V Test Results– Design Reviews– Changes to the Design
Quality Systems Compliance 39
Class Exercise-Design ControlsDr. Bright and Dr. Idea have found a novel way to produce a machine to determine if a heart attack patient has additional blockage in the coronary arteries that may be caused by the surgical bypass procedure (CABG). The machine non-invasively measures arterial flow by using Doppler sonar to determine if the arteries are blocked. It can be used in a patient’s home, by itself, on post heart attack patients who may be at risk for additional heart attacks. It transfers the data to a monitoring station at a EMS facility for 24/7 monitoring.
They have formed a company (The Bright-Idea Company), built a prototype and tested it in the lab on sheep and pigs. It worked great. Now they want to begin marketing it for use on humans.
1. Is the machine a medical device?2. What steps should Dr. Bright and Dr. Idea take before they can begin
marketing the machine? 3. What documents do they need to have on file?
Quality Systems Compliance 40
Manufacturing and
Servicing the Product
Quality Systems Compliance 41
Manufacturing and Service
A Medical Device Quality System is designed to assure that products are Safe
and Effective for their Intended Use
and
Consistently meet the specifications as defined by results of clinical and/or
detailed technical design and validation
Quality Systems Compliance 42
Documents Controls
• Career Opportunities– Documentation Control
Specialist– Change Order
Coordinator– Drafter
Quality Systems Compliance 43
Documents Controls
• Controlled System
• Review and Approval Required– Signature, Date – Authorized Personnel Listed in a Procedure
• Engineering Change Order Process (ECO)
• Electronic Records Require Special Security
Quality Systems Compliance 44
Purchasing Controls
• Career Opportunities– Purchasing Agent– Buyer– Supplier Auditor
Quality Systems Compliance 45
Purchasing Controls
• Written Procedures Required
• Supplier Selection Process– Approved Supplier List
• Purchase Orders – Detailed Specifications Needed – Supplier is Required to Have Current
Specifications
• Supplier Auditing
Quality Systems Compliance 46
Identification and Traceability
• Career Opportunities– Receiving and
Inspection Coordinators
– Shipping Coordinators– Quality Technicians
Quality Systems Compliance 47
Identification and Traceability
• Unique Identification of Product Through All stages of Receiving, Production, Installation, and Service
• Separate Accepted (Good) from Non- Conforming (Bad)
• Implants or Life Sustaining Product Requires Traceability to the User
Quality Systems Compliance 48
Production and Process Controls
• Career Opportunities– Calibration Technician– Maintenance
Technicians– Change Coordinators– Trainers– Process Validation
Technicians
Quality Systems Compliance 49
Production and Process Controls
• Written Instructions (SOP’s) Required• Environmental Controls
– Clean Rooms
• Personnel– Health, Cleanliness, etc.
• Contamination Control• Equipment
– Maintenance Schedules– Software Validation Required in Process Equipment
Quality Systems Compliance 50
Inspection, Measurement and Test Equipment
• Routine Calibration of Measurement Equipment
• Reference Standards Must Be Maintained
• Records Must Be Kept In Secure Areas
Quality Systems Compliance 51
Acceptance Activities
• Career Opportunities– Inspection Technician– Test Technicians– Non-conforming
product coordinator
Quality Systems Compliance 52
Acceptance Activities
• Written Procedures are Required for all Inspection and Test Activities
• Receiving Inspection
• In-Process Inspection and Test
• Final Inspection and Test
• Records
Quality Systems Compliance 53
Non-Conforming Product
• Non-conforming- Def: Does not meet Specifications
• Segregation, Identification and Status of Nonconforming Product is Required
• Material Review Board (MRB)
• Rework, Retest and Disposition
Quality Systems Compliance 54
Typical Inspection, NCMR, and Rework Process(The Happy Path)
C:\ My Documents\ QA Training\ NCMR-Reprocess.abc
Incoming Inspection SP-00050 SP-00031
Accept/ Reject
In Process (WIP)
SP 00044 Travelers SP 00004 In-process
inspection
Accept/ Reject
Accept/ Reject
Finished Goods
Final QA Release
SP-00042
NCMR SP00022
Sort/ Rework ScrapReturn to
VendorUse As Is
Reprocess Order
Scrap Log
Vendor Notification Corrective
Action Request FM 00036
Re-Inspect
Return material to
Stores, in-process,
MRB
Stores SP00020 Material
control Process
Vendor replacement Debit Memo
FM00026
FM 00035Reject
FM 00029 Debit Memo
Special IP IP's
FM
FM 00032
00043
FM 00049 (MO)
QA Quarrentine
Material
Reject
Accept/ reject
Reject
Reject
Close NCMR File in Quality Data
files
Receive Correcive Action (CPAN or
Vendor CAR)
Accept
Use as is rationale
CPAR/ CPAN required?
NO
Yes
ECO Rework, Repair, Update
disposition
Quality Systems Compliance 55
Corrective and Preventative Actions (CAPA)
• Career Opportunities– Quality Analyst– Quality Engineer– Complaint Coordinator
Quality Systems Compliance 56
Corrective and Preventative Actions (CAPA)
• Includes Internal and External Actions (Complaints to be covered after lunch)
• Corrective Actions- Actions Taken After Occurrence of the Event to Prevent Reoccurrence– Process Analysis– Failure Analysis – Procedure Review
Quality Systems Compliance 57
Corrective and Preventative Actions (CAPA)
• Examples of Corrective Actions– Review of Field Failures– Review of NCMR– Procedure Reviews
• Corrective Actions Should be Validated to Assure They Work
Quality Systems Compliance 58
Corrective and Preventative Actions (CAPA)
• Preventative Action- Actions Taken to Prevent a Problem from Occurring– Process Validations (IQ,OQ,PQ)– Trend Analysis of Complaints, Repairs – Internal Production Rework Trend Analysis
• (NCMR DATA)
– Supplier Audits and Reviews– Highly Accelerated Stress Screening Testing (HASS) – Highly Accelerated Life Testing (HALT)– Market Information Review from Competitors
Quality Systems Compliance 59
Corrective and Preventative Actions (CAPA)
• Communicate the Results of Analysis
• Management Reviews must Include CAPA Information
• Documentation of Actions is REQUIRED– Indication of the effectiveness of the Quality
System
Quality Systems Compliance 60
Labeling and Packaging
• Written Procedures Required• Label Integrity-
– Does the label remain legible for product life• Label Inspection
– Control of labels required• Label Storage
– Secure area– QA release
• Labeling Operations– Assure that labels are not mixed up– Recalls of FDA regulated product can be initiated by mis-
labeling• Serial Numbers
Quality Systems Compliance 61
Labeling and Packaging
• Packaging must be Designed to Assure That Products Are Protected During Transit and Storage– Shipping testing– Environmental testing (Temperature, Humidity)– Specialized labeling of the package may be
needed
• Sterile Packaging has Special Considerations
Quality Systems Compliance 62
Handling, Storage, Distribution and Installation
• Career Opportunities– Material Handlers– Stockroom Personnel– Shipping Personnel– Field Installation– Traffic Managers
Quality Systems Compliance 63
Handling, Storage, Distribution and Installation
• Official Release (QA) from Production to Storage (Stockroom) Required
• Mix-Ups Must be Prevented
• Prevention from Damage or Deterioration– Shelf Life– Stock Control-FIFO
Quality Systems Compliance 64
Handling, Storage, Distribution and Installation
• Procedures Required to Assure that Only “GOOD” Product is Released for Distribution
• Records of Following must be Kept by Manufacturer– Name and Address of Consignee (Company or
Person who Receives Product)– Quantity shipped– Date Shipped– Serial, Lot Numbers Shipped
Quality Systems Compliance 65
Handling, Storage, Distribution and Installation
• Installation Instructions Required (IQ)
• Installation of Equipment Must Be Verified
• Records Kept (if done by Mfgr.)
Quality Systems Compliance 66
Records
• General– Records Must be Legible– Security maintained– Available for Life of Product
• (min) 2 years past shipping date
Quality Systems Compliance 67
Records• Device Master Record (DMR)( Recipe)
– Design Specifications– Process Specifications– QA Procedures– Packaging Info Records– Labeling Info– Installation and Maintenance Info
• Device History Record (DHR)(As really Built)– Date of Manufacture– Quantity Manufactured– Quantity Released for Distribution– Acceptance ( Test) Records– Primary Labeling Information
• Quality System Record (QSR)– Quality Manual, Management Review Procedures, SOP’s, Generic
Training Procedures, Other Non-device Specific Quality Procedures
Quality Systems Compliance 68
Service
• Career Opportunities– Service Technicians
Quality Systems Compliance 69
Service
• Written Procedure For Service Required• Testing Post Servicing Required
– Record is part of the DHR
• Records Must Contain– Name and SN of Device– Date and Person Servicing Device– Service preformed and Test Results
• Service Information Must Reviewed for Complaints
Quality Systems Compliance 70
Statistical Techniques
• Valid Statistical Plans must be used for all sampling and testing to verify conformance to specifications
Quality Systems Compliance 71
Class Exercise Manufacturing and Service
The Bright-Idea Company received approval to market the machine . They have produced approximately 1000 of the machines, shipped 700 to their customers.
One afternoon, the final tester began to notice that the machines did not always work the way they were supposed to at the final test station. He was rejecting about 50% of them.
The design engineer in charge found that there was a sticky valve in about 50% of one of the lots of valves they received two months ago. It was hard to tell if the valves would always fail or not, because the problem was intermittent.
350 machines had been made using the lot with the defective valves.
You are the Quality Engineer responsible for Corrective Actions. What steps should you take next?
Quality Systems Compliance 72
Labeling
• Career Opportunities– Label Designer– Graphic Artist– Technical Writer
Quality Systems Compliance 73
Labeling21 CFR 801
• Section 201(k) defines "label" as a:
"display of written, printed, or graphic matter upon the immediate container of any article..." The term "immediate container" does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear "on the outside container or wrapper, if any there be, of the retain package of such article, or is easily legible through the outside container of wrapper."
• Section 201(m) defines "labeling" as:
"all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article" at any time while a device is held for sale after
shipment or delivery for shipment in interstate commerce.
Quality Systems Compliance 74
Over The Counter (OTC)Device Labeling
• Principal Display Panel 21 CFR 801.60 The principal display panel is that portion of the label which is intended to be displayed, presented, shown, or examined under customary conditions for retail sales.
• Statement of Identity 21 CFR 801.61The statement of identity of the device must be listed on the principal display panel. – It must list the common name – Indications for use– Bold type, – Reasonably sized generally parallel to the base of the package
• Net Quantity of Contents Statement 21 CFR 801.62 The label of an over-the-counter (OTC) device in package form must contain a statement of net quantity of contents in terms of weight, measure, numerical count; or a combination of numerical count and weight, measure.
Quality Systems Compliance 75
Prescription Device Labeling• Prescription Device 21 CFR 801.109 • A device which, because of any potentiality for harmful effect, or the supervision of
the method of its use, or the collateral measures necessary to its use is not safe unless under a practitioner licensed by law to direct use this device, and hence for which "adequate directions for use" cannot be written, is exempt from such provided:
– - It is in the possession of either a licensed practitioner or persons lawfully engaged in the manufacture of distribution of the product;
– - Its labeling bears an Rx statement, i.e., "Caution: Federal law restricts this device to sale by or on the order of a (Insert name of physician, dentist or other licensed practitioner;"
– - Its labeling bears information for use including, indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which the device can safely be used; and
– - All labeling other than labels and carton bears the date of issuance or date of the latest revision.
Quality Systems Compliance 76
Rx Medical Device Labeling- General Requirements
• Intended Use• Indications for Use• Contraindications for Use• Warnings, Cautions• Description of the Device• User Instructions• Specifications• Corrective Actions (Troubleshooting)
Quality Systems Compliance 77
FDA Actions for Mislabeling
• Warning Letters
• Mandatory Recall
• Injunctions to Stop Shipment
• Seizure
• Fines and Imprisonment
Quality Systems Compliance 78
FDA Legal Actions• SEC. 303. [21 U.S.C. 333] (a)(1) Any person who violates a provision of section 301 shall be
imprisoned for not more than one year or fined not more than $1,000, or both.
• Notwithstanding the provisions of paragraph (1) of this section, if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000 or both.
• Knowingly distributing drugs/devices in violation of section 503(e)(2)(A), shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.
• Any manufacturer or distributor who distributes drug/device samples by means other than the mail or common carrier whose representative, during the course of the representative’s employment or association with that manufacturer or distributor, violated section 301(t) because of a violation of section 503(c)(1) or violated any State law prohibiting the sale, purchase, or trade of a drug sample subject to section 503(b) or the offer to sell, purchase, or trade such a drug sample shall, upon conviction of the representative for such violation, be subject to the following civil penalties:
(A) A civil penalty of not more than $50,000 for each of the first two such violations resulting in a conviction of any representative of the manufacturer or distributor in any 10-year period.
(B) A civil penalty of not more than $1,000,000 for each violation resulting in a conviction of any representative after the second conviction in any 10-year period.
Quality Systems Compliance 79
Class Exercise- Labeling
• Review of Respironics REMStar® Heated Humidifier labeling for:– Indications for use– Contraindications– Prescription Statement– Description– Corrective Actions
Quality Systems Compliance 80
Complaints
Quality Systems Compliance 81
Complaint Definitions
• Any written, electronic, or oral communication that alleges deficiencies related to the – Identity– quality– durability– reliability– safety– effectiveness– or performance
of a device after it is released for distribution."
Quality Systems Compliance 82
World of Complaints
MDR
Incidents and near incidents
US EU
Some Definitions: Complaint: An expression of dissatisfaction concerning a product or services Quality Complaint: Any report that a product failed to meet its specifications for intended use, safety, performance or reliability; caused or contributed to a patient’s death; malfunctioned and could have caused or contributed to a death, or that the labeling was misleading or misbranding the product. Reportable Quality Complaints
US- Medical Device Reports- Report required if a death or serious injury occurred or could occur in similar circumstances due to a malfunction or improper labeling.
Quality Systems Compliance 83
Sources of Complaints
Complaints that shall be processed according to the GMP requirements may be received from:
• Customers by letter, credit memo, returned goods form, or phone;
• A manufacturer's representative, or other employees;
• The MedWatch voluntary reporting program; • A service or repair request; • Journal articles; or • The FDA
Quality Systems Compliance 84
What to do
1. Remain Calm 2. Gather details of the complaint:
a. Date complaint received, recipient’s name, recipient’s department, phone and extension number, if applicable.
b. Complainant’s information: name, address, telephone, and fax number if applicable.
c. Customer information: customer name, contact person, customer address, telephone, and fax number if applicable.
d. Patient information: patient name, date product placed in service, date of problem/event.
e. Device information: device name, model number, serial/lot number.
f. The form of communication of complaint: written, electronic, oral.
g. Details of complaint: Verify that enough information has been given in order that an analysis can be made of the type of complaint, specific malfunction or deficiency of product or service, or problem which has occurred.
h. If product has been returned, verify that an authorized RA number has been assigned
i. If the product has not been returned, try to have the product placed in Quarantine by the hospital, and arrange for return
j. Follow Up on Complaints k. Link to CAPA system
Quality Systems Compliance 85
Complaints-MDR
• Medical Device Report (MDR)-The MDR regulation requires that all manufacturers of medical devices notify FDA when they become aware of a death or serious injury that may have been caused or contributed to by one of their marketed devices and/or any malfunction of one of their devices which, if it were to recur, would be likely to cause or contribute to a death or serious injury.
Quality Systems Compliance 86
Class Exercise
Sandy Bright is Dr. Bright’s daughter. One day she was at a neighbor’s house (Ms. Consumer) when the machine Dr. Bright’s company made stopped working while Ms. Consumer was using it and Ms. Consumer had to go to the hospital. Ms. Consumer told Sandy to tell her Dad about the problem. Sandy told her Dad the next morning.
What Should Dr. Bright do and when?
Quality Systems Compliance 87
FDA Audits
Quality Systems Compliance 88
FDA Audits
• Career Opportunities– FDA Compliance
Officer– FDA Consumer Safety
Officer– Internal Auditor FDAFDA
Quality Systems Compliance 89
FDA Audits of a Device Manufacturer
• Types– QSR-Risk Based Approach– Targeted- Based on a Complaint/Recall
• Establishment must be registered• May Be Unannounced• FDA issues a Form 482-Notice of Inspection• If problems- FDA issues a form 483-Notice of
Observations• Possible Warning Letter if not corrected.
Quality Systems Compliance 90
Manufacturer’s Responsibilities
• Have Written Policy for FDA or other External Audits• Have Records Organized• Have an Escort at all Times• Have a Separate Room for the Auditor• Bring Information to Auditor• Be Courteous• Don’t offer any “bribes”
– Lunch– Trips to Hawaii– Baseball Game Tickets– Company Party
Quality Systems Compliance 91
Employee Responsibility
• Remain Calm
• Answer Questions Truthfully
• Don’t Volunteer Information
• Refer to Procedures
• If in Doubt, Refer to Supervisor/Escort
Quality Systems Compliance 92
Questions
Quality Systems Compliance 93
Test